BOSTON, MA--(Marketwire - September 5, 2007) - Although the number of new cancer drugs entering
clinical development more than doubled between the early 1990s and
mid-2000s, only eight percent of candidates with known fates won marketing
approval in the United States, according to a study recently completed by
the
Tufts Center for the Study of Drug
Development.
This approval rate compares with an overall U.S. marketing approval rate of
20% for all new drugs that began human testing in 1993-97, according to
Tufts CSDD.
In addition, the study found, U.S.-approved cancer therapeutics that
entered clinical testing in 1990-06 took an average of seven years to
complete the clinical development and approval process, compared with about
six years for all new drugs approved by the FDA during the same period.
"While commercial development of cancer treatments has dramatically
increased in the last dozen years or so, drug developers are still
challenged to boost success rates in this area," said Tufts CSDD Director
Kenneth I
Kaitin. "In today's market, increased R&D efficiency is synonymous with
long-term commercial viability, and improving success rates is key to
enhanced R&D performance."
The study assessed 1,111 cancer therapeutic or vaccine candidates that
originated at biotechnology and pharmaceutical companies worldwide or were
licensed by these companies from commercial, government, or academic
sources, and included only candidates in which the active ingredient had
not been approved previously for any indication.
Study results, reported in the September/October Tufts CSDD Impact Report,
released today, also found that:
-- The rate of clinical entry for the therapeutics studied by Tufts CSDD
more than doubled, from 33 in the early 1990s to 73 in the mid-2000s.
-- Overall U.S. success rates were low for compounds that have either
been abandoned or approved to date: 8% for all candidates, 10% for small
molecule drugs, 9% for monoclonal antibodies (mAbs) of all types, and 14%
for humanized mAbs.
-- Compared to all candidates and the small molecules, mAbs had the
lowest Phase 1-to-2 and Phase 2-to-3 phase transitions, but the highest
Phase 3-to-FDA review and review-to-approval transitions.
About the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development (
http://csdd.tufts.edu)
at Tufts University provides strategic information to help drug developers,
regulators, and policy makers improve the quality and efficiency of
pharmaceutical development, review, and utilization. Tufts CSDD, based in
Boston, conducts a wide range of in-depth analyses on pharmaceutical issues
and hosts symposia, workshops, and public forums, and publishes the Tufts
CSDD Impact Report, a bi-monthly newsletter providing analysis and insight
into critical drug development issues.
Contact Information: Contact:
Tufts Center for the Study of Drug Development
Peg Hewitt
617-636-2185
Business Communication Strategies
Peter Lowy
617-734-9980